Ampio's Phase 2 Study Of Inhaled Ampion In COVID-19 Patients Gets Underway

Ampio Pharmaceuticals, Inc. AMPE announced an update to its COVID-19 program that is evaluating its lead asset Ampion.

What Happened: Colorado-based Ampio announced the commencement of randomization and dosing of patients in the Phase 2 study, dubbed AP-019, of inhaled Ampion for the treatment of respiratory distress due to COVID-19.

Ampion is the low molecular weight filtrate of human serum albumin with the ability to modulate inflammatory cytokine levels. It has the potential to improve clinical outcomes for COVID-19 patients by reducing inflammatory cytokines correlated with the disease and respiratory complications, such as acute lung injury and acute respiratory distress syndrome.

The Phase 2 study initiation follows strong top-line results reported for Ampion in a Phase 1 study in late April.

In mid-June, Ampio said it received regulatory approval to expand enrollment of its AP-019 Phase 2 study to India, which is currently a hotspot for the pandemic.

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Why It's Important: Despite authorizations for vaccines, the COVID-19 pandemic continues to rage. Against this backdrop, it's essential to have effective treatment for the disease.

"Roughly 300 people per day are dying of COVID-19 in the U.S., with a seven-day average of 10,000 per day worldwide. There is a perception the vaccine rollout has ended the pandemic, but COVID-19 is likely to remain a concern for some time to come, and physicians need tools to treat it," said Michael Macaluso, President and CEO of Ampio.

What's Next: If the Phase 2 study confirms the efficacy seen in the Phase 1 study, an emergency use authorization filing for using Ampion in treating patients suffering from respiratory distress due to COVID-19 could ensue, Macaluso said.

In May, the company received approval for initiating a Phase 1 study, dubbed AP-018, of Ampion in patients exhibiting prolonged respiratory COVID-19 symptoms.

Ampio shares were advancing 1.7% to $1.81 at publication time.